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临床试验/NCT02295696
NCT02295696Unknown不适用

EMMA: Empowerment, Motivation and Medical Adherence

Steno Diabetes Center Copenhagen2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
270
试验地点
2
主要终点
HbA1c

研究概览

简要总结

EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.

详细描述

Traditionally, the success of patients to manage their diabetes has been judged by their ability to adhere to a prescribed therapeutic regimen, and efforts have been spent developing strategies to promote adherence. It is estimated that 20% to 50% of patients with chronic conditions are not adherent to their prescribed medication regimen, with non-adherence being defined as <80% adherence to prescribed, relevant medication. The treatment regimen often comprises several elements such as poly-pharmacy including insulin administration, self-monitoring of blood glucose, diet and physical exercise. It is thus not just a matter of 'taking a pill or not' but implies lifestyle changes, knowledge and competence, and internal motivation for self-management. The investigators developed a consultation program based on dialogue tools. The EMMA program aims to support medication adherence and blood glucose control by facilitating rapport, exploring patient concerns and challenges, enabling knowledge exchange and supporting goal-setting and action-planning. A pilot test of the program appeared feasible and acceptable to patients and health care professionals and showed significant decrease on HbA1c. EMMA is now ready to be tested in a randomized controlled study (RCT) study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults Type 2 diabetes ≥ 18 år
  • Type 2 diabetes ≥ 1 år
  • HbA1c ≥ 64 mmol/mol (≥ 8%) at the last three measures before randomisation
  • Taking medication for Type 2 diabetes • - Speak, read and understands Danish

排除标准

  • Participating in other intervention research projects during the trial period
  • Being treated by a psychiatrist or psychologist during the period
  • Reduced sight or blindness

结局指标

主要结局

HbA1c

时间窗: Baseline, 4½ month and 6 months after end of intervention period

Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months

次要结局

  • Self-management(Baseline, 4½ month and 6 months after end of intervention period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gitte Reventlov Husted

Researcher PhD

Steno Diabetes Center Copenhagen

研究点 (2)

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